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Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine

This study is currently recruiting participants.
Verified November 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03280342
First Posted: September 12, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Supernus Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg

Condition Intervention Phase
Migraine Headache Drug: IR-TPM (Topamax) Drug: XR-TPM (Trokendi XR) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
a crossover, randomized, double blind design in conjunction with intensive pharmacokinetic sampling and multiple administrations of a neurocognitive test battery to directly compare the effects on cognition of IR-TPM to XR-TPM in adults with migraine. The dose will begin at 25mg and titrated in 25mg increments to reach target dose of 100mg.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Controlled Oral Word Association Test (COWA)-generative phonemic fluency [ Time Frame: Baseline (Day 1) through Day 52 ]
    The primary outcome measure is the Controlled Oral Word Association (COWA: phonemic generative fluency). COWA was chosen as the primary endpoint since in previous studies of drug-induced cognitive impairment, this measure was sensitive to the effects of topiramate (Meador et al, 2003; Marino et al, 2012; Marino et al, 2015). The primary endpoint is a change in the COWA score from baseline to each post-dose assessment


Secondary Outcome Measures:
  • Measures of semantic verbal fluency [ Time Frame: Baseline (Day 1) through Day 52 ]
    Change in scores from individual baseline to each post-dose assessment on measures of semantic verbal fluency (e.g., Animals)

  • Digit Span Backward [ Time Frame: Baseline (Day 1) through Day 52 ]
    Change in scores from individual baseline to each post-dose assessment on measures of working memory (i.e., Digit Span Backward)

  • Digit Symbol Modalities Test (SDMT) [ Time Frame: Baseline (Day 1) through Day 52 ]
    Change in scores from individual baseline to each post-dose assessment on measure of psychomotor speed

  • Trails A & B [ Time Frame: Baseline (Day 1) through Day 52 ]
    Change in scores from individual baseline to each post-dose assessment on measures of executive function


Estimated Enrollment: 60
Actual Study Start Date: October 30, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IR-TPM (Topamax)
IR-TPM (Topamax)
Drug: IR-TPM (Topamax)
XR-TPM (Trokendi XR)
Drug: XR-TPM (Trokendi XR)
XR-TPM (Trokendi XR)
Active Comparator: XR-TPM (Trokendi XR) Drug: IR-TPM (Topamax)
XR-TPM (Trokendi XR)
Drug: XR-TPM (Trokendi XR)
XR-TPM (Trokendi XR)

Detailed Description:

The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely Trokendi XR®, regimen on cognition in adults with migraine.

The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months
  2. Male or female, ages 18-65
  3. Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.
  4. If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.
  5. Native English speakers (due to speech and language analysis)
  6. Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.

Exclusion Criteria:

  1. Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.
  2. Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.
  3. A history of nephrolithiasis
  4. Have previously taken topiramate
  5. Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280342


Contacts
Contact: Susan Marino, PhD 612-624-2964 marin007@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Susan Marino, PhD    612-624-2964    marin007@umn.edu   
Principal Investigator: Susan Marino, PhD         
Principal Investigator: Angela Birnbaum, PhD         
Prism Research Recruiting
Saint Paul, Minnesota, United States, 55114
Contact: Kevin Fitzgerald    651-724-5046    kfitzgerald@prismresearchinc.com   
Contact: Samuel Gillund    651-641-2901    sgillund@prismresearchinc.com   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Supernus Pharmaceuticals, Inc.
Investigators
Principal Investigator: Susan Marino, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03280342     History of Changes
Other Study ID Numbers: CETIM
First Submitted: September 1, 2017
First Posted: September 12, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Migraine
Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents